Download - pharma industry Italy
The Pharmaceutical Industry in ItalyFacts & Figures
October 2014
For further information: [email protected]; tel.: +39.06.67580345
Research & Development
Production
Market Access
HEALTH ANDQUALITY OF LIFE
INDUSTRIALGROWTH
ROLE IN HEALTHCARE,
VALUE FOR PATIENTS
More Productivity
More Resources
Acc
ess
toC
are
and Innovat
ion
Direct output + Upstream sectors
The pharmaceutical industry’s activities create health and wealth for the nation
Research & Development
Production
MarketAccess
Summary
CompetitiveBenchmarking
Every 4 months life expectancy increases by 1 month thanks to pharmaceutical innovation
The sector ranks 1st in Italy for R&D investments
Warning signs: decline in R&D employment and clinical trials
The pharmaceutical industry is the leading hi-tech employer in Italy
Highly qualified, more productive and better-paid jobs
Pharmaceuticals: at the top of European ranking for productivity and competitiveness
Public healthcare expenditure in Italy and the EU
Pharmaceuticals boost overall National Health System efficiency
It is necessary to optimize HC spending without penalizing medicine
WorldPharmaceutical
Trends
Slowing global pharmaceutical markets; growth moves to Emerging Economies
Increased complexity and costs of pharmaceutical research
The changing geography of global pharmaceutical production
Italy’s population is older than the EU average, but pharmaceutical expenditure is lowerLower prices and difficult access to innovation
Pharmaceutical industry in Italy: an asset the Nation must not lose
Research is life
Life expectancy increases 1 month every 4 months, 40% of the rise is due to pharmaceutical R&D
Italy: life expectancy at birth(years, male and female average)
All causes
Cardiovascular
Cancer
Respiratory
Digestive tract
Other causes
Italy: cumulative decrease in standard mortality rates (% change, deaths per 100 thousand inhabitants)
Since 1994
Since 1978
Research is life.More than 90% of Pharmaceutical Reasearch in Italy is funded by pharmaceutical companies
Source: Istat, OECD
40
50
60
70
80
90
1881 1911 1931 1951 1971 1991 2013
82
77
72
65
55
47
35
30
-30,0
-42,5
-21,1
-28,3
-44,1
-13,7
-47,5
-63,9
-18,2
-56,0
-62,6
-41,3
Living better and longer thanks to the pharmaceutical industry’s innovation
Source: CERM, Istat, OECD
Italy: population over 65 reporting their health to be good (mln)
Pharmaceutical R&D brings both breakthroughs and incremental innovationthat allows continuous improvements in quality of life and steady progress
in treatment efficacy, adverse effect reduction and ease of use
5-year survival rate and availability of new antineoplastic medicines
5-year survival rate
degree of pharmacological innovationhigherlower
average
Otherneoplasias
Stomach and lung cancer, leukemia
0
50
40
30
20
10
60
80
70
100
90
today20031994
0,0
2,0
4,0
1,0
3,0
3,3
2,4
1,8
+90%, 1,5 mln more
The Pharmaceutical sector leads Italy in Research and Development investments
Source: elaboration of Istat data
Intensity* of R&D activity in Italy (index, pharmaceutical industry=100)
Data on R&D investments in Italy (% on total)
Pharmaceuticals
Telecommunication
Precision and electromedical
equipment
Transport
Computer industry
High-mediumtechnology sectors
Machinery
Electronic devices
Chemicals and oil
Industry overall
* average of ratios (R&D expenditure/turnover) and (R&D employees/total employees)
Pharmaceuticaland health-oriented biotech
Internal R&D in other sectors
(46%)
Public R&D(43%)
Non profit (3%)
0 25 50 75 100
Enterprises overall
7%
403 biotech products developed in collaboration between pharmaceutical companies and SMEs
Source: elaboration of Istat, Aifa, Ernst&Young-Assobiotec data
The biotech sector in Italy is growing, with 176 companies investing on average 18% of revenues in R&D, far more than that for overall manufacturing (1%)
The pharmaceutical and biotech industries together employ about 7,100 researchersand invest €1,385 million in R&D
More than two thirds of Italian biotech activities are generated by pharmaceutical companies
Biotech SME research concentrates on early stages and feeds the innovationof pharmaceutical companies, which play a leading role in clinical development
The biotech pipeline in Italy, by phase and company type
Pre-clinicaland phase 1
Phase 2
Phase 3
Total
BiotechSMEs
Pharmaceuticalcompanies TOTAL
With additional 67 discovery projects
112
37
8
42
89
115
157 246
154
126
123
403
Warning signs: loss of R&D employment, decline in clinical trials
R&D employees in the pharmaceuticalindustry in Italy
Number of clinical trials in Italy
Source: elaboration of Istat, Aifa data
Clinical trials are also an important source of funding for regional and private healthcare organizations and an opportunity for patients to benefit
from advanced therapies
4,000
4,500
5,000
5,500
6,000
6,500
0
100
200
700
800
900
20062002 2004 2008 2010
300
400
500
600
Phase I and II
Other
5,950
2012
-21%
20092003 2005 2007 2011 2013
6,250
2001
The pharmaceutical R&D ecosystem
Patentprotection
BrandQuality, reputation,
Patients’ trust, industrial committment
Necessary tomaintain investments
InnovationResearch is Life.
Pharmaceutical R&Dis 90% supported by
companies
that must not be interrupted
continuous processa
From innovation to brand:
Pharmaceutical companies: Italy’s hi-tech engine
Source: elaboration of Istat, Eurostat data
The pharmaceutical industry in Italy:an asset that the nation must not lose
€ 28 billion of manufacturing value, of which 71% for export (€19.6 billions)
€ 2.3 billion in investments, of which €1.2 in R&Dand €1.1 in hi-tech plants and machinery
+64% export growth in the last 5 yearscompared to +7% in overall manufacturing
5,950 R&D employees
174 manufacturing plants
62,300 employees(90% graduates)
and other 64,000 in upstream sectors
Pharmaceutical industryand upstream sectors
Source: elaboration of Istat, Eurostat, Efpia, BCG data
Pharmaceuticals in Italy rank top in European manufacturing
Pharmaceutical manufacturing overall value (€ billion)
Per capita pharmaceuticalmanufacturing value (euro)
With reference to the value of pharmaceutical manufacturing, Italy ranks 2nd in big EUcountries after Germany, but ranks 1st for per capita manufacturing value
0
5
10
15
20
25
30
0
100
200
300
400
500
Source: elaboration on Istat
1991 1993 1998 2003 2008 2013 Q1 2014
Export: Medicinal products’ ranking out of 119 sectors in Italy
The growing importance of pharmaceuticalsfor Italian overall export
Pharmaceutical growth on international markets
Export as a % of pharmaceutical manufacturing in Italy
Source: elaboration of Istat, Eurostat data
The export growth is rooted in the high competitiveness of manufacturing in Italy, which reflects investments by enterprises and the quality of its Human Resources
Increase in pharmaceutical exports in 2008-2013 (% change, Eu15)
+29%
+64%
500 10 20 30 40
+29%
+64%
60 70 20131993 1998 2003 2008
40
80
70
60
50
30
20
10
0
71%
The pharmaceutical industry has become a highly specialized sector in Italy’s manufacturing industry
Source: elaboration of ICE-Istat data
Export-manufacturing specialization index(ratio between Italy’s exports as a % of world exports in pharmaceuticals and other manufactured goods;values greater than 1 indicate international specialization)
sectors 2008 sectors 2013
glass/ceramics/other materials 1,9 engineering 1,8
textile/clothing 1,9 textile/clothing 1,8engineering 1,7 glass/ceramics/other materials 1,8
other manufacturing products* 1,4 pharmaceuticals 1,3rubber and plastic 1,3 other manufacturing products* 1,3electric equipment 1,2 rubber and plastic 1,2metals 1,1 paper 1,1food/beverages/tobacco 1,0 metals 1,1paper 0,9 food/beverages/tobacco 1,1
pharmaceuticals 0,9 electric equipment 1,0
transport 0,8 transport 0,8oil and gas 0,7 chemical 0,7chemical 0,6 oil and gas 0,7wood (excl. furniture) 0,5 wood (excl. furniture) 0,5computers and electronics 0,2 computers and electronics 0,2
sectors 2008-2013
pharmaceuticals +0,4paper +0,2food/beverages/tobacco +0,1
engineering +0,1
chemical +0,1metals 0,0computers and electronics 0,0wood (excl. furniture) 0,0transport -0,1
oil and gas -0,1
textile/clothing -0,1glass/ceramics/other materials -0,1rubber and plastic -0,1other manufacturing products* -0,1electric equipment -0,2
*including furniture, jewelry and other products
In 2014 pharma export is still growing
Source: elaboration of Istat, Eurostat data
Average value of pharma export (index other Big Eu 2008=100)
Export 2014: Italy vs. Big Eu(% var. over previous year)
70
110
100
90
80
60
502008 2009 2010 2011 2012 2013 I sem.
2014
2013 2014*Italy
Industry total
Pharmaceutical
PharmaOther Big Eu -1,7
+13,8
-0,1
-1,6
+1,2
+3,1
As well as in 2013, pharmaceutical export achieves good results in 2014recording a growth higher than the overall industry
and the other Big european countries
* data for Italy are referred to January-August, data for other Big Eu to January-June
Other Big Eu
Italy
Key data for the pharmaceutical industry:a leading hi-tech sector in Italy
Source: elaboration of Istat, Eurostat data
% of pharma industry compared to overall hi-tech (*) in Italy
Employees Investmentsin production
and R&D
Value ofproduction
Export
(*) Pharmaceuticals, computer, electronic and optical equipment, aeronautics
0
20
30
40
50
10
30%
42% 44%
53%
Pharmaceuticals, Italy’s most competitive manufacturing sectorCompetitiveness indexfor manufacturing sectors in Italy (index Total manufacturing=100)
Source: elaboration of Istat, Banca d’Italia data
Other manufacturing
PharmaceuticalsBeverages
Chemical
Transport
Machinery
Rubber and plastic
Computers and electronics
Electronic equipment
Food
Coke and oil products
Total manufacturing
Textile and clothing
Metallurgy
Paper
Glass and minerals
Wood and furniture
Metal products
Maintenance, repairand installation of machinery
and electronic equip.
180100 1400 20 40 60 80 120 160
Export and productivity in overalleconomy of Italy (% ch., 2008-2013)
Product
ivit
ygro
wth
5%
10%
15%
20%
25%
0%
-5%
-10%
-15%
Export growth
40%20%0%-20%-40% 60% 80%
Pharmaceutical industry
Overall economy
The pharmaceutical industry is the mostproductive industrial sector in Italy
Source: Istat, Eurostat
Trend of productivity in Italy(index total economy in 1993=100)
Productivity: international comparison(overall % change since 2000)
Total Economy
PharmaceuticalIndustry
Italy
EU Countries
Germany
-10%
0%
10%
20%
30%
90
100
110
120
130
140
150
160
170
180
1993 1998 2003 2008 2013
PharmaceuticalIndustry
Overall economy
Maintaining and supporting the industrial value of the Italian pharmaceutical industry
Overall industry
Other hi-tech industrial
sectors
Pharmaceutical industry
72
61
100
0 20 40 60 80 100
47
38
100
0 20 40 60 80 100 0
100
44
17
20 40 60 80 100
Competitiveness Productivity R&D intensity
Innovation, competitiveness, productivity, R&D are necessary to growth: they are the key to the success of the pharmaceutical industry
Source: elaboration of Istat data
In its 2012 Annual Report, the Bank of Italy shows that the pharmaceutical industry recorded the highest increase in productivity over the last five years, compared to
other manufacturing sectors
Compared to the EU’s Big 5, Italy’s share in manufacturing is higher than its sales share
Source: elaboration of Istat data
Italy is a big pharmaceutical manufacturer even outstripping its own big market
Characteristics of pharmaindustry in Italy: index per employee(Overall manufacturing=100)
Italy’s role among the EU Big5 (% on total)
Pharmaceuticalmanufacturing
Pharmaceuticalmarket
(retail+non retail, ex factory values)
150 5 10 20 25Pharmaceuticalindustry
All sectors
Export
Investmentsin manufacturing
and R&D
Investmentsin environmental
protection
24%
18%
0 100 200 300
291
303
291
35025015050
Pharmaceutical companies’ leading rolein R&D and internationalization
Source: elaboration of Istat data, Farmindustria
Italian-owned companies internationalsales, % on turnover
R&D and manufacturing investmentsin Italy of foreign-owned companies(€ billion)
Pharmaceuticalindustry
Total manufacturing
industry
International sales Domestic sales
0%
20%
40%
60%
80%
100%
Data on pharmaceuticals is refered only to R&D intra-muros, net to clinical research
Pharmaceuticals
Transport
Machinery
Paper and printing
Chemical
Electronics
Metal products
Food
Petroleum
Glass and minerals
Rubber and plastic
Wood and furniture
Textile and clothing
Informatics
6000 200 400 800 1.000
Pharmaceutical and upstream sectors by Regions
Source: Farmindustria, Osservatorio Pharmintech, Istat
28,000 employees in pharmaceuticals, Lombardia ranks 1st for pharmaceutical and
biotech firms; 14,000 employees in upstream industries (chemicals, machinery, paper)
Lombardy
14,000 employees in pharmaceuticals42% of regional export (82% of hi-tech export)
6,600 employees in upstream industries(chemicals, packaging)
Lazio
Tuscany
2,700 employees, 6,000 in upstream industries (machinery, chemicals, packaging)
Veneto
3,300 employees in pharmaceuticals and 6,000 in upstream suppliers (machinery, chemicals, glass). Parma: pharma ranks third for export
Emilia Romagna
Centres of excellence of major international companies (3,000 employees in pharmaceuticals and related industries). Bari and Brindisipharma accounts for 31% of total export
Puglia
Campania
SicilyAbout 1,000 employees in pharmaceuticals and 4,000 in related industries. Catania: pharma accounts for 26% of total export
More than 1,000 employees in pharmaceuticals (100 in R&D) and 1,200 in allied industry
Abruzzo
900 employees in pharmaceuticals and
4,000 in upstream industries
2,800 employees in pharmaceuticals and upstream suppliers. Ascoli Piceno: pharma accounts for 62% of total export
Marche
6,000 employees in pharmaceuticals
Piemont and Liguria2,200 employees in pharmaceuticals
and 7,000 in upstream industries (machinery, chemicals, packaging)
4,000 employees in upstream industries (glass, chemicals)
Highly-skilled, productive and well-paid jobs
Source: Istat, Indagine Sistema Confindustria
Pharmaceuticalindustry
Overallmanufacturing
1) MS and Ph.D 55.6 19.6
2) High school 33.7 42.1
Other 10.7 38.3
Employees by educational level(% on total)
Thanks to investments and the quality of Human Resources, the pharmaceutical industry adds more value with higher salaries
when compared to the average of other industrial sectors.
(1 + 2) 89.3 61.7
Productivity and salaries, per employee(manufacturing industry=100)
Total 100.0 100.0Productivity (added value per employee)
Gro
ssw
ages
per
em
plo
yee
pharmaceuticalindustry
The role of pharmaceuticalswithin the National Healthcare Service
Italian healthcare spending compared to EU countries and the incidence of pharmaceuticals
Territorial pharmaceutical
spending* (11.35%) Hospital
pharmaceutical spending (3.5%)
Other hospital
expenditure (40.65%)
Italian Health System (NHS) Expenditure (% of total NHF, 2013)
Source: estimates on Oecd, Health Ministry, FMI
Public healthcare expenditure as % of GDPShare % of GDP(2012)
In Italy healthcare expenditure as a percentage of GDP and as per capita value is roughly 20% lower than in other large European countries
(for pharma spending, the gap is about 30%)
France
Germany
UK
ItalySpain
Big 5 (average)Other EU 15
EU 15 (average)USA
Other territorial
expenditure (39.5%)
Prevention (5.0%)
* Including mandatory patient copayment
9.0
8.6
7.8
7.17.1
7.97.5
7.68.0
In the future public healthcare expenditurewill grow less than in other European countries
Source: estimates on OECD, FMI data
Public HC spending, 2013-2030 increase(% on GDP, forecasts)
In the coming years, growing public HC spending in Italy will be due mainlyto population ageing, as opposed to other countries where growth will be related to
an excessive cost increase
0
1
2
3
4
5
0
1
2
3
4
5
Medicines and vaccines are tools for makingtotal healthcare expenditure cost-effective
avoidance of unnecessary surgery(eg. gastroduodenal ulcers)
prevention
slowing the degeneration or easing the symptoms of age-related diseases(eg. Parkinson’s and Alzheimer’s)
shortening hospitalization (eg. in case ofchemotherapy) or avoiding unnecessaryhospitalization (eg. in case of chronicdiseases)
reduced risks of disabling diseases
The appropriate use of medicines bringssavings for the NHS through:
Use of medicines for chronic diseases: a cost/benefit analysis(cardiovascular, respiratory, depression, Alzheimer’s)
Savings for NHS expenditure(less hospitalization,lessunnecessary surgery, slowing ofdegenerative deseases)
Non-NHS savings(less working days lost, higher productivity, lower welfare costs)
6.1
5.6
Expenditure in medicines 6.3
€ billions/year
Source: CER-Nib, Aifa
Savings achievable with vaccines
1 euro spent on vaccination is worth24 euro in patients therapy
One-day hospitalization costs €1,000
90% of the market consists of off-patent medicines, on account of the high growth of generics
TOTAL MARKET -1.2%
UnbrandedGenerics
Branded(in and off-patent)
-2.3%
+11.9%
2008 – 2013 annual average
Sales trends by percentage(public and private, pharmacy chain)
Source: Farmindustria elaboration of IMS Health data
Sales of reimbursable medicinesby patent coverage(% of total, in units, retail chain, Jan.-Aug. 2014)
IN-PATENT 6.7%
Off-patent branded
93.3%
62.8%
% of total
Unbranded generics 23.5%
Other 6.9%
OFF-PATENT
-2.8%
-3.6%
+5.2%
2014Jan.-Aug.
Off-patentIn-patent
Retail consumption by type of medicine (% on total)
Germania Francia Regno Italia SpagnaITA SPAFRAGER UK
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100% In all major European countries the off-patent market share (accessible by generics) is about 90% of the total pharmaceutical market
In Italy the difference is in the proportion between generics and branded off-patents, but this:
has no effect on public expenditure as Italy’s NHS only reimburses the lowest price
does not penalize patients who can choose to use generics after being mandatorily informed by their physician and pharmacists about this alternative
Off-patent market share in Italy is in line with other European countries
Source: elaboration Farmindustria of Assogenerici and IMS Health data
-27% the gap between Italy and other Big Euin terms of per capita public HC expenditure
Source: elaboration of Aifa, IMS, Eurostat data
Total exp. (net of interests)
HC public spending: cumulative % change 2009-2014
Public exp. (net of HC exp)
HC expenditure
Pharmaceuticalexpenditure*
Per capita pharmaceuticalexpenditure*
2%-6% -4% -2% 0% 4%
(*) terrritorial+hospital, excl. payback
Per capita public pharma expenditure in Italy and other big EU countries (territorial+hospital, €, market prices and net of VAT)
net of VAT
370
440
424
308
268
270
343
370
415
296
268
245
4000 100 200 300 500
Source: Farmindustria
National Healthcare Service with regionaldifferences that must be reduced
Regional Positive Listsfor access to new medicines
Prescription objectives for physicians
Two examples. Coloured Regions have specific healthcare systems in addition to the national systemand they differ one from another
The changing global scenario for the
pharmaceutical industry
North America
JP and South Korea
EU
BRICS + rest of the
World
Global pharmaceutical market (% on total)
Pharmaceutical market trends(CAGR %, USD)
Source: elaboration IMS
World AdvancedEconomies
BRICS + restof the World
Growth moves to the emerging economies, while the global market is slowing down
0
2
4
6
8
10
12
14
2007-2012 2012-20172007 2012 2017
2129
39
2523
181113 10
4235 33
7,9
4,5
11,3
4,5
0,8
12,5
Source: elaboration of IMS, Global Insights data
Advanced economies BRICS and rest of the World
0
20
40
60
80
100
20172006 2010 20142002
The shifting in global Healthcare demand fosters competition between advanced economies to maintain investments inside national borders and attract further investment
Total sales growth 2007-2017 (USD billion, CAGR)
Share of new investments in the global pharmaceutical industry (% on total)
Double-digit growth in emerging marketswhile advanced economies are stagnating
705
+11.3%
+4.5%
+12.5%
+0.8%149
288462
723552
2017201220070
1200
1000
800
600
400
200
The economic context in Asia and Oceania is luring R&D investment overseas
R&D spending(% on total, public and private)
R&D spending % var. 2007-2012(USD)
Source: elaboration on data extracted from The New England Journal of Medicine
0 5-5 10 152007 20122008 2009 2010 2011
North America and Canada
Europe Asia and Pacific (excl. Japan)
Japan
-1.9
-0.2
+5.7
+14.0
52.4
31.9
10.8
4.9 9.2
46.4
30.5
13.9
Rank 2005 Rank 2013 Rank 20171 United States 1 United States 1 United States2 Japan 2 Japan 2 China3 Germany 3 China 3 Japan4 France 4 Germany 4 Brasil5 Italy 5 France 5 Germany6 UK 6 Italy 6 France7 Spain 7 Brasil 7 Italy8 Canada 8 UK 8 Russia9 China 9 Canada 9 UK
10 Mexico 10 Spain 10 Canada11 South Korea 11 Australia 11 India12 Brasil 12 India 12 Spain13 Turkey 13 Russia 13 Mexico14 Australia 14 Turkey 14 South Korea15 India 15 Mexico 15 Australia
Population and economic growth are boosting demand for healthcarein emerging countries. In advanced economies cost containment measures
are squeezing markets.
Italy in the international ranking of pharmaceutical markets
Source: IMS
R&D costs are increasing while patentsare expiring within 50% of the branded market
Source: elaboration of Phrma and CERM data
20
30
40
50
60
70
100
80
90
10
02010 2011 2012 2013 2014
Italy: expiring-patent molecules, cumulative value compared to in-patentmarket (base year=2009)
Retail Total market (inc. non retail)
Rising costs and decreasing revenues (related to patent expiries) are a source of global structural change in the pharmaceutical sector
Global R&D costsfor innovative pharmaceuticals(estimate in billions of dollar)
today20010
200
400
600
800
1000
1200
1400
discovery
pre-clinical
phase IIImarket launch
discovery
pre-clinicalphase I
phase II
market launch
phase II
phase III
phase I
A structural change for the pharmaceuticalindustry around the World
Growing role of Emergingcountries
Ageing population in Advanced Economies
New medical needs(e.g. rare disease)
Increasing R&D costs
Patent deadline(50% of in-patent market)
Innovative technologies
Lower prices
Increasing business competition
Necessity of more resourcesfor R&D
Growing costs
Falling profit margin
Interdisciplinarity of research and development
Consequences on other sectors
Increasing number ofspecializations
Customized care (from 500 to 10,000 moleculartargets in next years)
Changingscenario
+Technological
“shock”
Radical changing in business organizationthrough major restructuring
=Research developed more on network than in laboratories
Thecompetitive benchmarking
of the Italian pharmaceutical industry
Source: elaboration of IMS data
Innovation: improving access to new products
Actual usein hospitals
Europeanauthorization
National authorization
RegionalPositive List
12-15 months
12 months
2 years
More than 2 yearsthe overall time
for access to new medicines
-40%
Even after market access, new products are penalized
by several restrictions
difference betweenItaly and big EU in per capita sales for new medicineslaunched between2008 and 2013
Source: BCG
Access conditions
Before Launch
National Guidelines
Risk Sharing Agreement
P&R setting (HTA)
Regional Guidelines
Authorization/PTOs(*)
Web-monitoring
Product Spend ceiling
Category Spend ceiling
Product Registries
National Spend Ceiling
After Launch
Hospital budget
Physicians prescription
Me-too drugs quotas
Me-too drugs quotas
Regi
onal
Nat
iona
lN
atio
nal
Regi
onal
Condition generally/widely applied Condition applied only in selected/specific cases
Market access conditions in Italy are hampered when compared to other big EU countries
(*) Prontuario Terapeutico Ospedaliero
0
50
100
150
200
250
300
350
400
450
0%
20%
40%
60%
80%
100%
Conditions at market launch for new medicinesin Italy and other big European countries
Source: elaboration of IMS data
Time of access to new products (time elapsing between EMA’s MAs and availability)
Share of new medicines compared to MAs released by EMA from 2011 to 2013(% on total)
80109
330364
427
221
69% 52%66%
39% 35% 35%
Qualitative index on access to new medicines authorized by EMA from 2008 to 2013
Source: elaboration of IMS data
Country ranking by specific indexes
Per capita consumption(standard units)
% of new medicines compared to MAs released by EMA from 2011 to 2013
Average price of new medicines available on each market
Time of access to new medicines compared to EMA MAs
1 23 45
1 43 52
1 32 45
1 43 52
TOTAL (average between 5 criteria)
1 42 53
1
2
3
4
N°molecules launched to local market from 2001 1 34 525
Source: elaboration of IMS data
Acces to Innovation: the gap in consumptionof new medicines between Italy and other Big Eu
-80
-70
-60
-50
-40
-30
-20
-10
0
2013 per capita consumption of new medicines with MAsreleased by EMA 2008-2013: comparisons between Italy and Big Eu(% gap)
CentralNervousSystem
Blood and hematopoietic
organs
Gastrointestinaland metabolic
Antimicrobial Anti-neoplastic and immunomodulators
Lower in-patent and off-patent prices in comparison to EU countries in pharmacies and hospitals
Source: Cergas Bocconi on IMS data
-15% Ita vs big EU
Total market
-19%
Pharmacy channel Total in-patent off-patent
-19% -17%
Hospital
-8%
Ex-factory prices of prescription medicines(bilateral comparisons, total market, index Italy=100)
Italy Spabig EU UK GerFra80
130
120
110
100
90
140
100
115
104107
111
132
Over 10 years of decreasing prices, much more pronounced in Italy than in the rest of Europe
Difference between medicine prices and inflation (percentage points)
Source: elaboration of Istat, Efpia data
-40
-30
-50
-10
-20
0
Italy big EU
-31% -14%
+29% +24%
Medicines prices (reimbursable and non-reimbursable)
inflation
Cumulative change 2001-2013
-60% -39%difference
In 2013 in Italy
• medicine prices (-0,7%)• inflation (+1,2%)
medicine prices -14%, inflation +12%2001-2006: difference -26%
medicine prices -19%, inflation +15%2006-2013: difference -34%
-60
-70
2003 2005 2007 2009 2011 2013
Italy Europe
Source: Farmindustria survey
Pro
1. Inefficient bureaucracy
2. Tax pressure
3. Complexity of labour legislation
4. Variability of regulatory framework
5. Complexity of tax legislation
1. Quality of Human Resources
2. Upstream quality
3. Quality of life/environment
4. Market size
5. Quality of clinical structures/access to expertise and skills
Cons
Main favourable and unfavourable factors for pharma company investments in Italy
Source: elaboration and estimates on Aifa, Farmindustria, Istat data
The pharmaceutical industry in Italy
Investments, Production and R&D
Direct tax, other taxes
and VAT
Wages and social security contributions
Public expenditure for medicines and vaccines (ex factory,
territorial+hospitalexcl. clawbacks)
Effective contribution of pharmaceutical
and related upstream sectors
Contribution of pharmaceutical industry with a
solely commercial presence
Direct economic contribution of the pharmaceutical industry and upstream activities, compared to public expenditure for reimbursed medicines – 2013 (€ bln)
Pharmaceutical industry
Upstream activities
12.113.7
3.83.3
6.3
4.1
2.3
4.1
3.9
0
8
10
12
2
4
6
14
16